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29 Maggio 2017

ODAC Recommends Approval of Epoetin Alfa Biosimilar

May 25, 2017 – The FDA’s Oncologic Drugs Committee voted (ODAC) 14-1 today to recommend approving a biologics license application (BLA) for epoetin hospira, an epoetin alfa biosimilar manufactured by Hospira. The BLA will now go to the FDA for consideration. The agency denied Hospira’s application for an abbreviated Biologics License Application in 2015. ODAC staff recommended approval, concluding that epoetin hospira is “highly similar to US-licensed … (leggi tutto)